GLP-1R Agonist Treatment for Opioid Use Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMilton S. Hershey Medical Center

About this trial

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:

• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?

The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.

The participants will:

* Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study

Eligibility criteria

Qualifiers

Age 18 to 75 years.

Body mass index (BMI) > 18.

Able and willing to provide informed consent prior to any study-related activities.

Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI > 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).

Disqualifiers

Age < 18 or > 75 years.

BMI <18.

Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.

Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.

Trial design

Treatments tested in this trial

  • Semaglutide Pen Injector
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Milton S. Hershey Medical Center

Lead sponsor

New York University

Collaborator

University of Maryland

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator